Special Announcement - Now Enrolling for FDA Approved Stem Cell StudyDr. Mitchell Sheinkop has completed training and is credentialed for the first of its kind FDA approved stem cell clinical trial for knee arthritis. Our clinic is now enrolling patients in this trial. Contact us at 312-475-1893 for details. Click here to learn more.

Abstract
Background:
In vivo amniotic fluid is known to contain a population of mesenchymal stem cells (MSCs) and growth factors and has been shown to assist in healing when used as an adjunct in procedures across multiple medical specialties. It is unclear whether amniotic fluid products (AFPs) contain MSCs and, if so, whether the cells remain viable after processing.
Purpose: To determine whether MSCs, growth factors, and hyaluronan are present in commercially available Amniotic Fluid Products.

Study Design:
Descriptive laboratory study.

Methods:
Seven commercial companies that provide amniotic fluid were invited to participate in the study; 3 companies (the manufacturers of PalinGen, FloGraft, and Genesis AFPs) agreed to participate and donated AFPs for analysis. The AFPs were evaluated for the presence of MSCs, various growth factors relevant to orthopaedics (platelet-derived growth factor ββ, vascular endothelial growth factor, interleukin 8, bone morphogenetic protein 2, transforming growth factor β1), and hyaluronan by enzyme-linked immunosorbent assay and culture of fibroblast colony-forming units. These products were compared with unprocessed amniotic fluid and 2 separate samples of MSCs derived from human bone marrow aspirates. All groups used the same culture medium and expansion techniques. Identical testing and analysis procedures were used for all samples.

Results:
MSCs could not be identified in the commercial AFPs or the unprocessed amniotic fluid. MSCs could be cultured from the bone marrow aspirates. Nucleated cells were found in 2 products (PalinGen and FloGraft), but most of these cells were dead. The few living cells did not exhibit established characteristics of MSCs. Growth factors and hyaluronan were present in all groups at varying levels.

Conclusion:
The Amniotic Fluid Products studied should not be considered “stem cell” therapies, and researchers should use caution when evaluating commercial claims that products contain stem cells. Given their growth factor content, however, AFPs may still represent a promising tool for orthopaedic treatment.

Clinical Relevance:
Amniotic fluid has been proposed as an allogenic means for introducing MSCs. This study was unable to confirm that commercial AFPs contain MSCs.

The basic principles behind the golf swing and the swing at home plate are not that much different. While the preferences may vary, when you break down the mechanics, there is similarity. Certainly there are differences between laying down a bunt and a 230-yard drive off the first Tee. The same differences are in play when putting is contrasted to the swing driving a 385-foot home run out of the park. In the several scenarios, the swing should look like one smooth, continuous motion that culminates with you holding a nicely balanced finish as the ball sails through the air. Within that motion however, is a series of techniques that each must be executed properly in order to produce the desired outcome.

Concentrating on golf swing mechanics, there is the Takeaway, Back swing, Transition, Impact, and Follow through. Continuing to explore the swing mechanics, backward movement of the shoulders and arms is followed by backward rotation of the spine, cocking of the hips, cocking of the wrists, timing, rotation of the pelvis, forward rotation of the spine, pushing and pulling of the arms and shoulders, guiding action and follow through.

Even if the physics behind my explanation is not perfect, the point here is that any pain and altered motion caused by injury or arthritis will affect your game. If you haven’t been able to play since last fall, now is the time to head out to the gym to catch up on strength training, stretching, with emphasis on spinal and pelvic rotation. Then there are the golf simulators and indoor driving ranges in and around Chicago.

If you experience pain in your muscles and joints along with limited motion, recent legislative changes in Illinois allow you direct access to the physical therapist. If after several sessions with the physical therapist, you haven’t realized the improvement you seek, it is time for an evaluation by an orthopedic surgeon. She or he, perhaps me, will complete a medical history and physical examination and review X-ray and MRIs of the effected anatomy. The end result of that intake may be a prescription for further PT, a prescription of pharmacologic management or in my case, a Regenerative Medicine/ Stem Cell procedure; that is a needle and not a knife.

I have documented in several recent scientific publications that Regenerative Medicine using either Bone Marrow Concentrate or Micro-fragmented Adipose tissue recovered by Liposuction will allow you to play 18 holes of golf this upcoming season. At times concentrated and then processed Platelets offer an opportunity for a patient afflicted with arthritis or limited by bodily injury to return to an active lifestyle and enjoy a full schedule of outdoor recreational pursuits. Please make note that my regenerative menu of services is based on your own cells and proteins that have been proven to work and meet FDA and FTC guidelines.

The weather forecast is improving and the sun was out today; the opening of both the baseball and golf season is only a about a week or so away. I say “Play ball.”

“Why bother with the truth when you can make it all up”
David Baldacci

“As practicing physicians, scientists, and regulatory experts we have increasingly observed aggressive advertising and sales tactics being used by alternative health clinics (chiropractors, naturopaths, and acupuncturists) as well as physicians and mid-level providers to market “stem cell” treatments derived from birth tissues. One example is full-page print ads in major newspapers used to recruit elderly patients and others desperate for effective treatments to seminars where prospective patients are informed that they can be injected with millions of live and functional stem cells to relieve their symptoms. The products used are derived from birth tissues such as umbilical cord blood and/or Wharton’s Jelly or amniotic fluid/membrane. Many patients spend thousands of dollars on these therapies to treat orthopedic problems and/or a myriad of other incurable diseases. The seminars typically state that there are robust clinical data supporting the safety and efficacy of these products, regardless of the condition or pathology being treated, when no such clinical evidence exists. In addition, some manufacturers of birth tissues claim that their products contain live and functional stem cells, while other manufacturers do not make these same claims. Claims of live cells are not compliant with FDA regulations, which require this type of donor tissue to be non-viable.

To date, two research investigations have been conducted which document the content of commercially available amniotic and cord blood products sold by FDA-registered manufacturers (those regulated solely under section 361 of the Public Health Service (PHS) Act). We are aware of additional investigations that are in progress. Both Berger, et al. and Becktell from the Fortier laboratory at Cornell University, found that these amniotic and cord blood products did not contain live or functional stem cells. In addition, both research groups found that many of the growth factor levels in these products were significantly lower than those found in common autologous orthobiologic products like platelet-rich plasma. Fortier et al. did report that these products do contain proteins like lumican and cytokines, which may positively impact orthopedic injuries, but concluded that more research is needed before any claims can be made. While there are early clinical data on stem cells that are isolated from fresh birth tissues and culture expanded, these studies used treatments which are not analogous to the commercially available, cryopreserved, FDA registered birth tissue products. In addition, it should be noted that while the clinical evidence in this area is evolving and one day may support the clinical efficacy of cryopreserved birth tissues for some orthopedic applications, no such evidence exists at this time. In particular, we are aware of FDA approved clinical trials that use these tissues for diseases such as knee osteoarthritis, which are ongoing.

Consensus Statement: The aggressive marketing approach currently used by practitioners and clinics regarding various birth tissue products as safe and effective “stem cell therapy” is not supported by the existing scientific literature.”

My column regarding ACL ruptures appeared last Friday. That afternoon, I received the following inquiry and comment from a reader, regarding the prognosis and possible early preventive interventions for a significant knee injury.

“I am one of relatively few patients who has had the Bone Marrow Concentrate treatment for a fully-torn (not-retracted) ACL tear and to date, I’ve had what I’d consider to be an amazing recovery. I read your latest blog post and just thought I’d let you know that I’m back to very aggressive skiing (including small but non-trivial jumps). However, I did want to ask, if you would be willing to comment, if there are actions or periodic diagnostics, you’d recommend to maximize the chances that I’m still happy skiing 10,20,30 years after the injury? I understand you probably can’t comment but nevertheless wanted to let you know I was also a real-life person who had a significant knee trauma with multiple surgical consults all agreeing it was fully torn and required surgery (to return to high-level skiing) and now have a fairly normal looking ACL in MRI (per independent radiologist) and am back to 100% with activities that require a lot of knee stability. I did do two rounds of same-day BMA reinjections and a bunch of platelet injections but no surgery.”

The answer is an orthopedic assessment at three-year intervals to look for markers of post traumatic osteoarthritis such as loss of terminal extension and asymmetrical flexion. The MRI is helpful in detecting moderate arthritic changes but the latest development, the needle scope, allows an orthopedic surgeon to directly examine the meniscus and cartilage in an office setting. The concern is post traumatic arthritis, cartilage defects that will progress, and meniscal damage not always seen on the MRI. Here are some thoughts on early intervention with Cellular Orthopedic and Regenerative Medicine options.

A recent Study Compared the Efficiency of Needle Arthroscopy Versus MRI for Meniscal Tears and Cartilage damage. Needle arthroscopy (NA) may be a less costly and more accurate option for diagnosis and treatment of meniscal tears and early onset post traumatic arthritis than MRI, according to a study published in the February issue of Arthroscopy. Researchers collected data on costs for care and accuracy, including procedures for both false-positive and false-negative findings well as private payer reimbursement rates. They compared outcomes using the global knee injury and osteoarthritis outcome score (KOOS). Patients were followed and evaluated over a two-year period.

There are several restorative options now available when conservative therapies for the treatment of knee degenerative processes, such as non-pharmacological interventions, systemic drug treatment, and intra-articular therapies offer only short-term benefits or fail. Before resorting to surgery; be aware that encouraging preliminary results have been reported using mesenchymal stem cells (MSCs), either alone or in association with surgery. My clinical published research documents success with using your Bone Marrow Concentrate for joint restoration and combating progression of posttraumatic arthritis. Additionally, I have published an article concerning another source for joint restoration, micro-fractured adipose tissue. The latter has created a huge interest in the context of cartilage regeneration due to its wide availability, ease to harvest and richness in mesenchymal cell elements within the so called stromal vascular fraction. Moreover, MSCs from adipose tissue are characterized by marked anti-inflammatory and regenerative properties, which make them an excellent tool for regenerative medicine purposes.

Following injury or wear, limitations need not be limited to professional, college and high school athletes

Last week, my column focused on the post traumatic ravages of the National Football League season; and getting ready for next cycle of body demolition. Those who watched the championship game saw several players assisted off the field following violent trauma. Even the President announced that he would prefer his son not play football. While professional, college and high school competitive sports enjoy high profile, there are the average recreational sports and fitness enthusiasts who progressively experience a diminution of ability to participate in a sought-after activity by virtue of injury or wear and tear; be it basketball, running, cycling, skiing, hockey, fitness endeavors, volleyball, golf, soccer, sailing; so, on and so forth.

As an example, a 67-year-old man presented in my office last week after having read my column, with progressive pain in his left knee and inability to partake in his long-time recreational passion, volleyball. I completed his intake centered on the taking of his medical history, completed an orthopedic physical examination, and ordered X-rays. He brought a recent MRI study to the appointment. The physical therapist who assists me objectively documented his physical findings so we would have pretreatment measurements. Additionally, my therapeutic recommendation is always based on more than an X-Ray and MRI, but also includes the objective and reproducible Range of Joint Motion and assessment of joint stability.

After review of all the above, I administered informed consent for a Bone Marrow Concentrate intervention into his left knee as a means of postponing, perhaps avoiding a Total Knee Replacement and assisting in his return to recreational volleyball. While there are several options for intervention into the arthritic or injured joint including adipose and blood-based alternatives, I recommended Bone Marrow Concentrate for his moderately arthritic knee as a means of providing Concentrated Platelets, Concentrated Growth Factors, anti-inflammatory Cytokines, Adult Mesenchymal Stem Cells, Precursor Cells, Marrow Adipose Tissue, and Hematopoietic Cells, all consistent with FDA compliance requirements. There are mandatory Federal Drug Administration and Federal Trade Commission regulatory standards of compliance in Regenerative Medicine; patients must be cautious when choosing the minimally invasive Cellular Orthopedic option. It takes an office visit, physical assessment and review of images by a board-certified specialist in the regenerative medicine decision making process; not merely attendance at a seminar. Some patients will not meet inclusion criteria, their needs would be better served by accepted surgical norms.

At age 67, there is little chance at Cartilage Regeneration for my patient, but there is a high probability of Joint Restoration; that is increased motion, diminution of pain and the return of ability, in this patient’s case to play volleyball. He will wear an off-loader brace for six weeks, partake in physical therapy and then gradually return to his Chicago Park District three games a week routine. The patient will have reached his competitive goals through care based on the scientific evidence and outcomes documentation. As long as I introduced the subject of competitive goals, off I go to ski in Colorado next week; about a year after having undergone Cellular Orthopedic interventions to both of my arthritic hips and both of my arthritic knees. Without the biologics, not only would I be unable to ski, I would be ready for two knee replacements and two hip replacements. I should have listened to my mother and stuck to the piano and violin.

To learn more about continuing to reach your competitive goals, visit my web site www.sheinkopmd.com or call and schedule a consultation 847-390-7666).